Acne vulgaris treated with low-dose isotretinoin and associated laboratory abnormalities, including liver function test and lipid profile abnormalities retinoid, low-dose isotretinoin, acne, laboratory monitoring, lipid profile, liver enzymes, adverse effect
Conditions
Interventions
Adult acne vulgaris patients receiving low-dose isotretinoin as part of routine treatment, monitored for lipid profiles and liver function test. Patients must not have pre-existing abnormal lipid prof
Treatment
Acne vulgaris patients receiving low-dose isotretinoin
Sponsors
Faculty of Medicine, Srinakharinwirot University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Male or female patients aged more than 18 years who have been diagnosed with acne vulgaris by a physician and have an indication for isotretinoin, as follows 1. Moderate to severe acne vulgaris, defined according to the Acne severity grading for treatment of the Dermatological Society of Thailand 1.1 Moderate acne vulgaris: Presence of inflammatory lesions including multiple to numerous papules or pustules (more than 10 lesions), or a few to several nodules (less than 5 lesions). 1.2 Severe acne vulgaris: Presence of numerous papules or pustules (more than 10 lesions), or a few to several nodules (more than 5 lesions), or the presence of sinus tracts. 2. Acne with risk of scarring (acne-prone scarring). 3. Recalcitrant acne, defined with reference to the JAAD Guidelines of Care for the Management of Acne Vulgaris, including one or more of the following 3.1 Acne not responding to standard therapy, including oral antibiotics or topical acne treatments, for at least 6-12 weeks. 3.2 Acne that remains persistently severe or worsens, e.g., clearly present or numerous papules, pustules, or nodules, chronic inflammatory acne, or rapid relapse immediately after discontinuation of treatment. 3.3 Female patients with polycystic ovary syndrome (PCOS) whose acne does not respond to hormonal therapy. 4. Willingness to participate in the study and provision of written informed consent. 5. Ability to attend follow-up visits, including a clinical follow-up at month 1 and laboratory monitoring at months 2, 4, and 6, respectively.
Exclusion criteria
Exclusion criteria: 1. Patients who are currently receiving or have received oral isotretinoin or other oral vitamin A derivatives within 6 months prior to study enrollment. 2. Female patients who are pregnant, have a history of amenorrhea suspicious for pregnancy, plan to become pregnant, or are unable to practice effective contraception. 3. Breastfeeding patients. 4. Patients with a history of hypersensitivity or allergy to isotretinoin, vitamin A, or vitamin A derivatives. 5. Patients with contraindications to oral isotretinoin, including but not limited to the following 5.1 Patients receiving medications that may affect liver function, such as statins, azole antifungal agents, antimicrobial agents (e.g., anti-tuberculosis drugs), antiviral agents (e.g., nevirapine), antiepileptic drugs, or immunosuppressive agents (e.g., methotrexate). 5.2 Patients with ocular surface dryness secondary to systemic diseases such as sjogren's syndrome. 5.3 Patients currently receiving tetracycline-class antibiotics, due to the potential risk of pseudotumor cerebri (idiopathic intracranial hypertension). 5.4 Patients receiving medications that may affect serum lipid levels, such as lipid-lowering agents. 6. Patients with abnormal baseline laboratory results, defined as Grade 1 (mild) or higher according to the Common Terminology Criteria for Adverse Events (CTCAE). 7. Patients with significant underlying medical conditions, including severe hepatic or renal impairment, pancreatitis, severe hyperlipidemia, or coronary artery disease. 8. Patients with a history of severe depression or psychiatric disorders that may interfere with treatment adherence or outcome assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of newly developed abnormal triglyceride levels during follow-up. at months 2, 4, and 6 after treatment initiation Serum triglyceride levels. Abnormalities will be graded according to the Common Terminology Criteria for Adverse Events version 5.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of newly developed abnormal cholesterol levels during follow-up. at months 2, 4, and 6 after treatment initiation Serum cholesterol levels. Abnormalities will be graded according to the Common Terminology Criteria for Adverse Events version 5.0.,The incidence of newly developed abnormal liver function test during follow-up at months 2, 4, and 6 after treatment initiation Serum alanine aminotransferase levels. Abnormalities will be graded according to the Common Terminology Criteria for Adverse Events version 5.0.,Identification of risk factors associated with laboratory abnormalities (lipid profiles and liver function tests) in patients treated with low-dose isotretinoin. at baseline and at months 2, 4, and 6 Baseline demographic and clinical characteristics, including age, sex, body mass index, current concomitant medications, alcohol consumption, and smoking status. | — |
Countries
Thailand
Contacts
Public ContactSalinee Rojhirunsakool
Faculty of Medicine, Srinakharinwirot University
Outcome results
None listed